FDA Picks Lilly, Regeneron for Fast-Track Review Program Targeting New U.S. Drug Manufacturing Plants

In a move aimed at bolstering domestic pharmaceutical production and reducing drug shortages, the U.S. Food and Drug Administration has enlisted Eli Lilly and Regeneron — along with five other companies — for a new pilot program that allows regulators to begin reviewing manufacturing facilities while they are still under construction. The initiative, called PreCheck, marks a shift from the traditional sequential review process and could shave up to 14 months off the typical timeline, according to the FDA.

CNBC reported on Monday, citing FDA official Benjamin Nichols, that the seven selected participants are Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin. The program is part of a broader push by the Biden administration to bring critical drug manufacturing back to U.S. soil, a priority underscored by supply-chain disruptions during the COVID-19 pandemic.

Under PreCheck, FDA inspectors will evaluate facility design, equipment, and processes during construction, enabling them to identify and correct potential compliance issues early. The agency estimates this concurrent review approach will help manufacturers avoid costly delays and bring new medicines to market faster. For drugmakers like Lilly and Regeneron, which have both expanded their U.S. footprint in recent years, the program offers a streamlined path for new production lines.

The U.S. Department of Health and Human Services, which oversees the FDA, did not immediately respond to a request for comment from Reuters. The pilot is expected to run for an initial period, with the agency evaluating its effectiveness before considering broader adoption.